# K092877: Indiscal Aspiration Device and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Nov 17, 2009 after 60 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922881 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942987: Nucleotome L Kit, Surgical Dynamics, Inc. (1995) Summary page 1.
- K931109: Nucleotome E Kit, Surgical Dynamics, Inc. (1994) Summary page 1.
- K923525: Nucleotome 3.5 MM Automated Percutaneous Lumbar, Surgical Dynamics, Inc. (1993) Summary page 1.
- K914282: Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter, Surgical Dynamics, Inc. (1991) Summary page 1.
- K902778: Surgical Dynamics Nucleotome II Tissue Aspir/Cuter, Surgical Dynamics, Inc. (1990) Summary page 1.
- K040919: Nucleotome Probe Set, Model 21200, Clarus Medical, LLC (2004) Summary page 1.

## Indications for use
The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Source page: https://510kreport.com/device/K092877
Methodology: https://510kreport.com/methodology